Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control

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AAMI

Reference34 articles.

1. ISO 10012 Measurement management systems—Requirements for measurement processes and measuring equipment

2. ISO 11462-2 Guidelines for implementation of statistical process control (SPC)—Part 2: Catalogue of tools and techniques

3. ISO 14253-1 Geometrical product specifications (GPS)—Inspection by measurement of workpieces and measuring equipment—Part 1: Decision rules for proving conformity or nonconformity with specifications

4. ISO 14971 (R2010) Medical devices—Application of risk management to medical devices

5. ISO/ASTM 51205 Practice for use of a ceric-cerous sulfate dosimetry system

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